Luna CPAP and Auto CPAP System
K-Number: K153387 · 2016-09-08
Applicant3B Medical, Inc.
Decision Date2016-09-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Luna CPAP and Auto CPAP System is a medical device manufactured by 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-09-08 under approval number K153387. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Luna CPAP and Auto CPAP System?
Luna CPAP and Auto CPAP System is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by 3B Medical, Inc.. The 510(k) number is K153387.
When was Luna CPAP and Auto CPAP System approved by the FDA?
Luna CPAP and Auto CPAP System received FDA 510(k) clearance on 2016-09-08, under approval number K153387.
What company makes Luna CPAP and Auto CPAP System?
Luna CPAP and Auto CPAP System is manufactured by 3B Medical, Inc..
What is the FDA product code for Luna CPAP and Auto CPAP System?
The FDA product code for Luna CPAP and Auto CPAP System is BZD.
Other Devices by 3B Medical, Inc.
Related Devices (Code: BZD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.